The Food and Drug Administration (FDA) has approved Octagam 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis.
Dermatomyositis is a rare autoimmune disease characterized by chronic inflammation, scarring or loss of cells in multiple organs, and damage to blood vessels. The disease is typically diagnosed in adults between 50 and 60 years old, although it can occur in children, and females are more commonly affected than males. The cause is unknown.
The approval was largely based on the results of the phase 3 ProDERM study (NCT02728752). In that 16-week, double-blind, placebo-controlled clinical trial, patients were randomized to receive Octagam (2g/kg) or placebo every four weeks. That 16-week trial was followed by a 24-week open label extension phase.
During the initial 16-week phase, 79% of patients receiving Octagam responded positively to treatment compared to 44% of those receiving placebo. After switching to Octagam in the extension period, patients from the placebo group attained a similar response rate at Week 40 as the Octagam treated patients did at Week 16 (i.e., approximately 70% for minimal improvement). The safety and tolerability profile of Octagam was consistent with previously reported safety outcomes of IVIg.
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